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How do I write a hazard that occurs and the preventive control for it?

Hazard Analysis Preventive Control FDA Food Safety Tool PCQI

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#1 Kubramilller

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Posted 01 March 2021 - 03:15 PM

Hi everyone, I am pretty new PCQI person at the factory for baked product. I have couple questions, how do I write a hazard that occurs and the preventive control for it.  And has anyone use FDA food safety builder tool. I have started one but my laptop decided to reboot and I lost my work on the builder, (I saved it before it happened) but it keeps giving me an error. Any suggestions? Thank you.  

 

 



#2 Scampi

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Posted 01 March 2021 - 03:48 PM

Have you taken a HACCP course?  That's the best place to start

 

Otherwise, I use this decision tree (not for FDA)

https://www.inspecti...7674768_eng.pdf

 

Use the link and look for form 8-CCP decision tree


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#3 Kubramilller

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Posted 01 March 2021 - 04:09 PM

No, I have not taken the HACCP yet, just taken PCQI certification online training. 

I am having a little hard time to collect documents to keep records. 

I will check out the link you sent 

Thank you for the answer. 



#4 Scampi

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Posted 01 March 2021 - 04:24 PM

Do you have a master registry of documents?  In the beginning when you're learning, it's helpful to have a list

 

Document Name

Who's responsible for completing it

Frequency

 

Then you can tick things off as you get then and help you to see what's missing

 

This can be a huge job until you get your feet under you  :)


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#5 Charles.C

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Posted 02 March 2021 - 06:51 AM

Surely the OP's query is definitively answered in the PCQI (free) manual/worked example(s) ?. And training analogs.


Kind Regards,

 

Charles.C


#6 kfromNE

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Posted 02 March 2021 - 12:57 PM

The FDA food safety builder is helpful when you're new. I used it at the beginning but then switched to an excel document. The tool isn't as user friendly as it should be. And I worried about the program not working with all of my items saved on it. You can create an excel document based upon the example in the training.

 

For potential hazards - appendix 1: Potential hazards for foods and processes



#7 Kubramilller

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Posted 02 March 2021 - 01:45 PM

Thanks everyone, I have tried to use FDA Food Safety Builder, in the middle of my work my laptop turned off, I was not able to open the food safety builder back up (even it was saved). It keeps giving errors. How do you do it on the excel? any suggestion for it?

Scampi, what are master registry of documents, what kind of list i should be making?

I have learned so much from my PCQI training but practicing them is the hard part for me, since it is my first job experience as a quality assurance specialist

Thank you everyone again,



#8 Scampi

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Posted 02 March 2021 - 02:00 PM

The document registry should list ALL of the policies/programs  the SOPS that relate to them and then the records used to monitor those programs --see my example below

 

 

Policy                        SOP                                                              Record

 

GMP                         GMP Training                                        Training Record

GMP                          GMP Monitoring                                    Daily GMP Monitoring

                                  Onsite Visitors                                        Visitor Sign In                  


Edited by Scampi, 02 March 2021 - 02:01 PM.

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#9 kdscha777

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Posted 02 March 2021 - 02:49 PM

I think it's  good to aken a HACCP course that's the best place to start...otherwise you can take some guide from its related forum and links 



#10 Kubramilller

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Posted 02 March 2021 - 03:19 PM

Thanks Scampi, that is helpful. I will check them.

I am planning to take HACCP soon, thank you kdscha777 



#11 Charles.C

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Posted 02 March 2021 - 04:05 PM

No, I have not taken the HACCP yet, just taken PCQI certification online training. 

I am having a little hard time to collect documents to keep records. 

I will check out the link you sent 

Thank you for the answer. 

Hi Kubramillier,

 

I am confused.

You mention having "taken" PCQI Certification.

I would have thought HACCP is the core topic of this.

 

@Scampi - is the "Preventive Control (PC)" implemented in the (CFIA) tree/manual linked in Post 2 the same "PC" as within FSMA ?. Offhand, the definition looks different and it's usage in the CFIA "tree" is  to my mind almost unintelligible? (eg what the heck is "partial control" ?)


Kind Regards,

 

Charles.C


#12 kfromNE

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Posted 02 March 2021 - 04:16 PM

Charles - they are similar. - see page 4. A Food Safety Plan is in essence a HACCP plan with more requirements/considerations.

 

https://www.fda.gov/.../99547/download



#13 Scampi

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Posted 02 March 2021 - 04:43 PM

Charles, come on!  You know that some hazards have more than 1 control!

 

Let's see

 

Poultry slaughter example

 

I have VERY LITTLE control over what the animals are fed.............

The grower has to provide a flock sheet for the birds coming to the plant BEFORE they arrive-------------partial control

The other parts of this control are 

 

1) only using approved growers

2) reviewing the flock sheets prior to the flock arriving and notifying CFIA if meds were used and no withdrawl noted

3) tissue samples that are done on a routine rotating schedule

 

No one "control" is adequate to deal with the hazard in this case

 

Or use freezing as another example

In poultry there are standards about how cold a bird must be over time   an X/Y axis with an inversion

 

I can control water temp, but birds can't pick up too much water

I can control speed of chiller........but that's tied directly to the water temp

I can control the inverse temperature relationship

 

I cannot do those things with 1 control e.g. the water temp

 

I can think of a million examples when more than 1 control is needed to control a particular hazard


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#14 Charles.C

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Posted 02 March 2021 - 07:08 PM

Charles, come on!  You know that some hazards have more than 1 control!

 

Let's see

 

Poultry slaughter example

 

I have VERY LITTLE control over what the animals are fed.............

The grower has to provide a flock sheet for the birds coming to the plant BEFORE they arrive-------------partial control

The other parts of this control are 

 

1) only using approved growers

2) reviewing the flock sheets prior to the flock arriving and notifying CFIA if meds were used and no withdrawl noted

3) tissue samples that are done on a routine rotating schedule

 

No one "control" is adequate to deal with the hazard in this case

 

Or use freezing as another example

In poultry there are standards about how cold a bird must be over time   an X/Y axis with an inversion

 

I can control water temp, but birds can't pick up too much water

I can control speed of chiller........but that's tied directly to the water temp

I can control the inverse temperature relationship

 

I cannot do those things with 1 control e.g. the water temp

 

I can think of a million examples when more than 1 control is needed to control a particular hazard

 

Hi Scampi/kfromNE,

 

My criticism centers around the meaning/intention/acceptability of "Control".

 

From the document linked in Post 12 -

Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food, to ensure safe food is produced, including -

 

 

From 21CFR117.135 -

(a)(1) You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.

 

 

I am curious how 1st (red) is "reconciled"  with the (2nd red) (see below).

 

I deduce CFIA has chosen to "translate" the 2nd (red) into "partial".  Hmmm.

 

So - What the heck is "significantly ......." (eg how does one  validate either of these non-explicit interpretations [in fact, IIRC, this concept is a semi-rebirth of ICMSF's long gone CCP2]).

 

Again quoting -

 

In an FSP, validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards. The extent of validation activities may be less rigorous for some preventive controls than others, or may not be required (e.g., sanitation controls).

 

 

In fact, from elsewhere -

The following activities do not require validation

  • Food allergen controls

  • Sanitation controls

  • Recall plan

  • Supply chain program

  • Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.

https://www.fdareade...2/17/validation

 

How very convenient. Sort of like defining them as HACCP (PRPs).

 

I deduce my first query is often answered by Statistics.


Kind Regards,

 

Charles.C


#15 kfromNE

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Posted 03 March 2021 - 12:59 PM

I don't disagree Charles. I was merely stating how the FDA compares the two. A hope of many of us - USDA and FDA will be combined into one entity to be run by the USDA. Which would hopefully get rid of the nuances of FSMA



#16 mgourley

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Posted 03 March 2021 - 01:11 PM

I don't disagree Charles. I was merely stating how the FDA compares the two. A hope of many of us - USDA and FDA will be combined into one entity to be run by the USDA. Which would hopefully get rid of the nuances of FSMA

 

Well, since FSMA is federal law, I doubt merging of FDA and USDA would have much effect on the nuances.

 

Marshall







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